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The early signs of biosimilar competition for Humira appear to
confirm that this is a watershed, global event for the biosimilars
market - with intense competition arriving at an unprecedented
rate. A sign of things to come has already arrived in countries
such as Denmark and Italy.
On 20 November, Denmark's regional procurement organization,
Amgros, announced preliminary results from two tender competitions
for Humira - and Amgros immediately indicated that AbbVie's
reference product Humira "does not have the lowest price" and is
thus "not the winner with the highest ranking". Amgros
representatives stated that offers were received from five
pharmaceutical companies in both competitions. The prices submitted
and the ranking of companies will not be disclosed until 1 January
2019 and 1 April 2019, respectively. However, the two tender
contracts were for different time periods from January to March
2019 and from April to December 2019 (with an option to extend the
arrangement further). The national tender for Humira in Denmark is
a further indication of the intense pricing pressure that AbbVie is
encountering from biosimilar competitors. The full details of the
contract will not be revealed by Amgros until the first quarter of
2019. Nevertheless, the preliminary results are likely to have
knock-on consequences in other EU markets - as a benchmark for
other tenders and for countries that use Denmark in international
reference pricing (IRP) baskets. Regional authorities in Denmark
have forecast that the introduction of cheaper biosimilar versions
of Humira in the hospital system will generate savings of at least
DKK335 million (USD51 million) next year.
Separately - but on the same day - reports emerged in Italy that
five regional authorities - Piedmont, Valle d'Aosta, Lazio,
Sardinia, and Veneto - have joined forces to conduct a single
tender for the biosimilar versions of Humira, which generates local
sales amounting to EUR285.0 million. Italy's public procurement
agency, CONSIP, will conduct the tender on behalf of the five
regional administrations, and the cost to regional authorities
involved is set to fall from EUR47 million previously to
approximately EUR16 million, down 65%. The region tender offer will
serve as a good basis for gauging the cost savings and price
competition that Humira biosimilars can generate in Italy.
Biosimilars uptake in Italy has been increasing during recent
years, although there remain strong regional variations, and the
fact that regions are now banding together for tenders is precisely
designed to counteract these variations.
Clearly, this is only the beginning, and many of the bigger
markets are still assessing their approach to biosimilar
adalimumab. But the early signs are that payors at both national
and regional level are taking unprecedented steps to encourage
price competition among the new biosimilars, with Europe again
leading the way - although the FDA is also pushing through
biosimilar approvals in this area.
